The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
67
Percentage of Participants who Develop MAKE90
Time frame: From Day 0 (day of surgery) up to Day 90 post-surgery
Number of Participants With Adverse Events (AEs)
Time frame: Up to Day 90 post surgery
Percentage of Participants who Develop AKI
Time frame: From Day 0 (day of surgery) up to Day 7 post surgery
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline up to Days 30, 60 and 90 post surgery
Number of Participants With New or Worsened Chronic Kidney Disease (CKD)
Time frame: Baseline up to Day 90 post surgery
Percentage of Participants who Develop MAKE30 and MAKE60
Time frame: From Day 0 (day of surgery) to Day 30, Day 60 post surgery
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University of Stanford Medical Center
Stanford, California, United States
James A Haley Veteran Affairs Medical Center - NAVREF - PPDS
Tampa, Florida, United States
John Hopkins Hospital
Lutherville, Maryland, United States
Baystate Cardiac Surgery
Springfield, Massachusetts, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
CHI Health Nebraska Heart
Lincoln, Nebraska, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Richmond VA Medical Center NAVREF PPDS
Richmond, Virginia, United States
Gold Coast University Hospital
Southport, Queensland, Australia
...and 24 more locations